Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Brigham and Women's Hospital
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This study is designed to determine the efficacy and safety of colchicine in patients with chronic kidney disease.
What data supports the idea that Colchicine for Chronic Kidney Disease is an effective drug?The available research does not provide specific data supporting the effectiveness of Colchicine for treating Chronic Kidney Disease. Instead, it discusses other treatments and factors related to kidney disease, such as risk assessment tools and therapies for different kidney conditions. Without direct evidence from the provided information, we cannot conclude that Colchicine is effective for this condition.348911
Do I have to stop taking my current medications for this trial?The trial requires stopping certain medications. You cannot use immunosuppressive or anti-inflammatory medications, systemic antimicrobial therapy, P-gp inhibitors, moderate-strong CYP3A4 inhibitors, or medications that may cause myopathy or rhabdomyolysis within 30 days before enrollment. You must also be on specific medications like ACE inhibitors or ARBs if your urine albumin-to-creatinine ratio is high.
Is the drug Colchicine a promising treatment for chronic kidney disease?The provided research articles do not mention Colchicine as a treatment for chronic kidney disease, so there is no information to suggest it is a promising treatment for this condition.367913
What safety data exists for colchicine in treating chronic kidney disease?The provided research does not contain specific safety data for colchicine or its brand names (Colcrys, Mitigare, Gloperba, Lodoco) in the treatment of chronic kidney disease. The studies focus on skin cancer risks and porphyria in CKD patients, unrelated to colchicine treatment.1251012
Eligibility Criteria
Adults aged 21-80 with chronic kidney disease, inflammation (high C-reactive protein levels), and heart strain are eligible. They must be able to consent, follow the study plan, have an eGFR of 15-75 mL/min/1.73 m2, and a high urine albumin level. Exclusions include colchicine allergy, recent hospitalization or surgery, severe heart failure or other serious conditions that increase risk.Inclusion Criteria
My kidney function, measured by eGFR, is between 15 to 75 mL/min.
I am between 21 and 80 years old.
Exclusion Criteria
I have a heart condition I was born with.
I have had surgery in the last 30 days or will have it during the study.
My kidney function has worsened recently.
I have had a heart transplant.
I have been diagnosed with an autoimmune or auto-inflammatory condition like rheumatoid arthritis or lupus.
My heart failure is severe, classified as stage C or D.
My heart's pumping ability is below 40%.
I have moderate to severe liver disease.
I have had a heart attack or severe chest pain before.
I have heart valve problems causing symptoms.
I have not taken antibiotics or had an infection in the last 30 days.
I have kidney failure and have had a transplant or need dialysis.
I am currently taking medication that affects how drugs are processed in my body.
Treatment Details
The trial is testing if colchicine can safely reduce inflammation in patients with chronic kidney disease compared to a placebo. Participants will either receive colchicine or a placebo pill without knowing which one they're getting to measure the true effect of the drug.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ColchicineExperimental Treatment1 Intervention
Colchicine 0.3 mg once daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo once daily
Colchicine is already approved in United States for the following indications:
🇺🇸 Approved in United States as Colcrys for:
- Gout
- Familial Mediterranean Fever
Find a clinic near you
Research locations nearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
[Porphyria cutanea tarda-like aspects in two prolonged hemodialysis patients (author's transl)]. [2006]In two female patients with prolonged maintenance hemodialysis, blisters and postbullous erosions could be observed. One case also showed raised amounts of uroporphyrin I and III in the urine.
[Porphyria cutanea tarda in a chronic hemodialysis patient]. [2011]About 3 years after commencing hemodialysis for chronic renal failure, a 39-year-old man developed cutaneous lesions of the face and hands which were compatible with porphyria cutanea tarda (PCT) clinically and histologically. There was no evidence of familial PCT, excessive alcohol consumption, iron overload, chronic liver disease. It was impossible to measure urinary porphyrins because of anuria. Fecal and erythrocytic porphyrins were within normal limits. Plasma porphyrins, however, were markedly elevated, and in an assay using high performance liquid chromatography, uroporphyrin accounted for 72% and 7-carboxyl porphyrin for 24%. Review of past reports of PCT associated with hemodialysis revealed that the most characteristic feature was a significant increase of plasma porphyrins, mainly uroporphyrin. This increase is difficult to explain by accumulation due to failure of adequate clearance. Participation of factors affecting uroporphyrinogen decarboxylase activity seems likely.
[New results concerning the effectiveness of therapy of chronic glomerulonephritis. Results of cytostatics-anticoagulants-aggregation inhibitors, cystostatics-anticoagulants-aggregation inhibitors-prednisone and cystostatics-prednisone therapy, derived from a retrospective study]. [2013]The indication and effectiveness of the immunosuppressive therapy of chronic glomerulonephritis is now as ever controversial. As a result of a retrospective therapy study in an at least one-year therapy with cytostatics, thrombocyte aggregation inhibitors and anticoagulants (CAA-therapy, n = 27), additional prednisone therapy (CAAP-therapy, n = 95) and cytostatic-prednisone therapy (CP-therapy, n = 33) we find favourable results for the CAA/CAAP-therapy in the nephrotic syndrome and glomerulonephritides with distinct clinical exacerbation also in sclerosations in histology. Clinically inactive nephritides with exclusive urinary findings and sclerosations cannot be influenced therapeutically.
[Renal hemodynamics in sandimmun therapy of patients with various morphological forms of chronic glomerulonephritis]. [2013]The results of the authors' investigations demonstrate that sandimmun in mean therapeutic doses given to patients with chronic glomerulonephritis produces nephrotoxic complications in rare cases even when nephroprotective vasodilators are not used. However, administration of the latter (nifedipin, tenziamin, etc.) improves renal hemodynamics that is increases effective renal plasm and blood flow to normal values, lowers renal vascular resistance after 2-3 months of therapy. In patients who have not received vasodilators normalization of renal hemodynamics occurs by the treatment month 6.
Molecular, immunological, enzymatic and biochemical studies of coproporphyrinogen oxidase deficiency in a family with hereditary coproporphyria. [2006]A 27-year-old woman who had recurrent pain in renal bed since 1998 with increasing character, was stationary admitted. The patient showed dark urine, complained of hair loss and took since 1994 a hormonal oral contraceptive. No photosensitivity was observed. Determinations of urinary porphyrin metabolites in 1998 revealed a porphyria cutanea tarda like excretion pattern with elevations of uro- (1767 nmol/24 hr, normal
[Instructions and implementations for percutaneous renal biopsy. Guidelines for the therapy of glomerular nephropaties]. [2017]This series of articles on the management of glomerulonephritis (GN) has been prepared by a team of experts in the evidence-based format consistent with peer review of published data. Each author was asked to review the literature for his assigned histological type, with emphasis on therapy and limited to adult studies. The age limit was not considered for minimal change disease and focal segmental glomerulosclerosis, because of the high prevalence of these glomerulopathies in children. The particular treatment recommendations for each type of glomerular disease were graded by each author according to the amount of evidence provided in these reviewed studies. The first two articles concentrate on indications and techniques for kidney biopsy. Each subsequent article focuses on and describes the highest level of evidence supporting the recommendation for therapy in IgA nephropathy (Ig-GN), minimal change nephropathy (MCN) and focal segmental glomerulosclerosis (FSGS), membranous glomerulonephritis (MGN), lupus nephritis, ANCA-associated vasculitis, HCV-associated cryoglobulinaemia and renal involvement in paraproteinemic disorders. The article on IgA nephropathy emphasises the importance of carefully evaluating both clinical and histologic findings before settling on the treatment. The recent, renewed interest in steroids and many immunosuppressive agents is discussed in detail. Recommendations related to the patient's age are also provided. MCN and FSGS are treated together because these forms share similar evidence-based recommendations. For both of these diseases, in fact, the initial treatment approach in children should be prednisone or prednisolone for four to six weeks. The therapeutic response in adults is slower than in children, but adults experience fewer relapses and a more prolonged remission. There is also a discussion on treatment of relapse, frequent relapsing disease and true steroid-resistant disease as well as the role of new immunosuppressive agents. Membranous nephropathy is a frequent cause of nephrotic syndrome in adults and, in one third of these patients, leads to end-stage renal disease. However, the treatment of this form is as yet a matter of discussion. Based on extensive critical review of the literature, the following recommendations are put forward: (a) no treatment in the absence of nephrotic syndrome; (b) patients with heavy proteinuria should receive a 6-month treatment with i.v. methylprednisolone (MP) pulse therapy for three consecutive days followed by oral MP (0.4 mg/kg/day) (months 1, 3, 5) and chlorambucil or cyclophosphamide (months 2, 4, 6); (c) the dosage of chlorambucil or cyclophosphamide should be lowered in older patients; (d) cyclosporine is a second-choice treatment. The treatment of lupus nephritis depends on the histologic class. No specific treatment is usually necessary for class I and IIA. Oral steroids are indicated in patients with class IIb, proteinuria and active systemic disease. Steroids and azathioprine are the treatment of choice for patients with class III and IV, but cyclosporine can be an effective alternative therapy. Cyclophosphamide is more effective than azathioprine when severe acute renal involvement is present. The treatment of ANCA-associated vasculitis depends mainly on clinical presentation, oral prednisone + oral or i.v. cyclophosphamide are generally effective. In the most severe cases, the association of MP pulse therapy with cyclophosphamide is probably more effective. Plasma exchange is probably justified in unresponsive patients. Azathioprine should replace cyclophosphamide during the maintenance therapy. In HCV-associated mixed cryoglobulinemia the treatment also depends on the severity of renal involvement. The treatment for chronic HCV infection involves alpha interferon alone or preferably in combination with ribavirin. Aggressive therapy, including i.v. MP, plasmapheresis and cyclophosphamide is primarily reserved for patients with acute severe disease, as manifested by progressive renal failure, distal necroses requiring amputation, or advanced neuropathy. Uncontrolled studies suggest that this regimen can improve renal function. Renal involvement is a common problem in paraproteinemic disorders that include multiple myeloma, Waldentrom's macroglobulinaemia and monoclonal gammopathy. The most common renal diseases in this setting are cast nephropathy, primary amyloidosis cast nephropathy, primary amyloidosis, and light chain deposition disease that are related to the overproduction of monoclonal immunoglobulin light chains. The approach to therapy varies with the cause of the renal dysfunction. Patients with amyloidosis or light-chain deposition disease are generally treated with chemotherapy, but the most effective therapy for myeloma kidney is prevention by minimising the risk factors that promote light chain filtration and subsequent obstruction by cast formation within the tubules. Chemotherapy or stem cell or bone marrow transplantation to decrease filtered light chain load, prevent volume depletion and maintain high fluid intake to reduce light chain concentration within the tubular lumen are indicated in almost all the patients.
Estimated glomerular filtration rate reversal by blood pressure lowering in chronic kidney disease: Japan Multicenter Investigation for Cardiovascular DiseaseB CKD study. [2021]Patients are diagnosed as having chronic kidney disease (CKD) if estimated glomerular filtration rate (eGFR) is
Association between First Nations ethnicity and progression to kidney failure by presence and severity of albuminuria. [2022]Despite a low prevalence of chronic kidney disease (estimated glomerular filtration rate [GFR]
[What do we know about chronic kidney disease at the beginning of the 21st century?]. [2018]Data are presented on the number of chronic kidney disease (CKD) patients and on the most common causes of the disease, with special reference to data collected at the Registry of Renal Replacement Therapy by Dialysis and Kidney Transplantation in the Republic of Croatia. Emphasis is put on the very high cost of managing patients with end-stage CKD. As currently there is no drug able to halt progression of kidney damage in CKD, attention is focused on early detection of renal disease, screening of CKD patients, specific therapy, slowing down disease progression, and treatment of complications and comorbidities. The role of general practitioners and compliance of patients who have to decide on the mode of renal replacement therapy, as well as of continuous education of nephrologists and public awareness of renal diseases is underlined.
Risk of Non-melanoma Skin Cancer in Patients with Chronic Kidney Disease and its Relationship to Uraemic Pruritus. [2022]This study investigated the risk of non-melanoma skin cancer (NMSC) in pre-dialysis patients with chronic kidney disease (CKD) and explored associated risk factors. A population-based cohort of 1,515,858 Taiwanese CKD patients was included. The standardized incidence ratio (SIR) for incident NMSC was determined. Compared with the general population, a 1.14-fold risk of NMSC was found in the CKD cohort. NMSC risk was significant in patients with pre-dialysis stage 5 CKD and anaemia (1.48-fold), and in those with uraemic pruritus after long-term antihistamine treatment (1.38-fold). A higher SIR for NMSC was found in younger patients with CKD (age
[Risk Scores in Patients with Chronic Kidney Disease]. [2019]Assessing the risk of adverse outcomes associated with chronic kidney disease (CKD) is important for physicians and affected patients alike. Categorizing CKD according to the cause-GFR category-albuminuria category (CGA)-classification system proposed by KDIGO already provides a semi-quantitative assessment of risks. The more recent development of the "Tangri"-formula provides a means to quantify the risk of progression for patients with CKD stage G3a-G5 (eGFR 10 - 59 ml/min/1.73 m2) to kidney failure requiring kidney replacement therapy. To use this formula, the variables age, sex, eGFR and albuminuria are required (4-variable equation). An extended formula with the additional parameters calcium, phosphate, bicarbonate and albumin (8-variable equation) allows an even more precise estimation of progression risk. In patients with advanced CKD, stage G4 or higher (GFR category ≥ 4, i. e. eGFR < 30 ml/min/1.73 m2), models recently developed by the CKD-prognosis consortium can not only be used to predict the risk of kidney failure but also the risk of cardiovascular disease events and death. The risk estimators can be accessed through websites (http://kidneyfailurerisk.com, http://www.ckdpcrisk.org/lowgfrevents/) and via downloading of the respective "apps". These novel tools may prove useful for health care decisions and as a basis for discussions with CKD patients.
Risk of Skin Cancer among Patients with Chronic Kidney Disease Treated with Ultraviolet B Phototherapy for Uraemic Pruritus: A Nationwide Cohort Study. [2022]The safety of ultraviolet B (UVB) phototherapy with respect to cutaneous carcinogenesis has not been established for patients with chronic kidney disease. To investigate this issue, a nationwide cohort study of 10,805 patients with advanced chronic kidney disease was conducted using data from the National Health Insurance of Taiwan, the Taiwan Cancer Registry, and the national death registry. After a median follow-up of 75 months, 16 of 2,161 patients in the UVB group and 63 of 8,644 patients in the non-UVB group developed skin cancers. Compared with the non-UVB group, patients in the UVB group did not show an increased risk of skin cancer (hazard ratio 1.066; 95% confidence interval 0.584-1.944), non-melanoma skin cancer (hazard ratio 1.067; 95% confidence interval 0.571-1.996), or cutaneous melanoma (hazard ratio 1.009; 95% confidence interval 0.115-8.879). In addition, patients who received more UVB phototherapy did not show an increased risk of skin cancer. UVB phototherapy appears to be a safe treatment for uraemic pruritus in patients with chronic kidney disease.
[What is confirmed in the treatment of chronic kidney disease?] [2022]Chronic kidney disease (CKD) is defined as a relevant excretion of albumin into the urine or a reduction of the glomerular filtration rate (GFR) over a longer time period of ≥ 3 months. The causes of CKD are manifold, whereby the association with diabetes mellitus is the most frequent cause. Early stages of CKD affect approximately 10% of the total population. The frequency of cardiovascular events, the risk of dependency on dialysis and the all-cause mortality increase exponentially with a decrease in the GFR and an increase in albuminuria. The guidelines of the German College of General Practitioners and Family Physicians (DEGAM) and the organization Kidney Disease: Improving Global Outcomes (KDIGO) recommend referral to a nephrologist with a GFR of ≤ 30 or ≤ 60 ml/min/1.73 m2 in the presence of various cofactors. This means that the majority of CKD patients are treated by general internists or general practitioners. This article gives a concise summary of current data on the treatment of CKD and its associated complications in clinical practice. It refers to the current guidelines and also new study results which could perspectively expand the therapeutic repertoire.